Preoperative Oral Antibiotics With vs Without Mechanical Bowel Preparation to Reduce Surgical Site Infections Following Colonic Resection: an International Randomized Controlled Trial.
NCT ID: NCT04161599
Last Updated: 2022-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
968 participants
INTERVENTIONAL
2022-03-01
2024-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The role of mechanical bowel preparation in patients needing colonic surgery is yet to be elucidated.
No randomised controlled trials have assessed the impact of mechanical bowel preparation combined with oral antibiotics on the incidence of surgical site infections after colonic surgery, compared with oral antibiotics only.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Parenteral Antibiotics Compared to Combination of Oral and Parenteral Antibiotics in Colorectal Surgery Prophylaxis
NCT02505581
Mechanical Bowel Preparation and Oral Antibiotics Before Colon Cancer Surgery
NCT03475680
Mechanical Bowel Preparation and Oral Antibiotics Before Rectal Cancer Surgery
NCT03491540
Prophylatic Effect Preoperative Antibiotics With Mechanical Bowel Preparation in SSIs
NCT03856671
Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
NCT00613769
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Routine antibiotics for the intravenous and oral prophylaxis of colorectal surgery will be used.
Experimental group: Patients undergoing elective colonic surgery that involves colonic resection.
The antibiotic prophylaxis in this group will be composed of:
An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses) the day before surgery, plus mechanical bowel preparation with Sodium picosulfate, light magnesium oxide, and anhydrous citric acid (10 mg - 3.5 g - 10.97 g per dose/ 2 doses the day before surgery) + An intravenous antibiotics pattern of cefuroxime 1,5 g and metronidazole 1 g at anesthetic induction.
Control group: Patients undergoing elective colonic surgery that involves colonic resection.
The antibiotic prophylaxis in this group will be composed of:
An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) and metronidazole (250mg / 8h, 3 doses)
\+ An intravenous antibiotic pattern of cefuroxime 1,5 g and metronidazole 1 gr at anesthetic induction.
In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time prolongs for more than three hours or if there is an intraoperative bleeding over 1000cc.
There will not be a placebo treatment. Subject compliance will be evaluated according to the usual practice in surgical care field
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Oral + Parenteral prophylaxis + Mechanical Bowel Preparation
Drug: Extra dosage - cefuroxime (750mg) I.V
Procedure: Colonic Surgery Both groups undergo colonic surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
Drug: Cefuroxime 750mg oral An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) the day before surgery.
Drug: Metronidazole 250mg oral An oral antibiotic pattern of metronidazole (250mg / 8h, 3 doses) the day before surgery.
Drug: Sodium picosulfate, magnesium oxide, citric acid anhydrous 15.08 g oral An oral laxative for bowel cleansing (2 doses) the day before surgery.
Drug: Metronidazole 1 g Intravenous An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.
Drug: Cefuroxime 1,5 g Intravenous An intravenous antibiotic pattern of cefuroxime 1,5 g during anesthetic induction.
Cefuroxime (750mg) I.V
Extra dosage
Colonic Surgery
Colonic Surgery
Cefuroxime 750mg oral
Oral prophylaxis
Metronidazole 250 MG Oral Tablet [Flagyl]
Oral prophylaxis
Metronidazole 1 g Intravenous
IV prophylaxis
Cefuroxime 1,5 g Intravenous
IV prophylaxis
Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral
Laxative for bowel cleansing
Oral + Parenteral prophylaxis
Drug: Extra dosage - cefuroxime (750mg) I.V In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc
Procedure: Colonic Surgery Both groups undergo colonic surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
Drug: Cefuroxime 750mg oral An oral antibiotic pattern of ciprofloxacin (750mg / 12h, 2 doses) the day before surgery.
Drug: Metronidazole 250mg oral An oral antibiotic pattern of metronidazole (250mg / 8h, 3 doses) the day before surgery.
Drug: Metronidazole 1 gr Intravenous An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.
Drug: Cefuroxime 1,5 g Intravenous An intravenous antibiotic pattern of cefuroxime 1,5 g during anesthetic induction.
Cefuroxime (750mg) I.V
Extra dosage
Colonic Surgery
Colonic Surgery
Cefuroxime 750mg oral
Oral prophylaxis
Metronidazole 250 MG Oral Tablet [Flagyl]
Oral prophylaxis
Metronidazole 1 g Intravenous
IV prophylaxis
Cefuroxime 1,5 g Intravenous
IV prophylaxis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cefuroxime (750mg) I.V
Extra dosage
Colonic Surgery
Colonic Surgery
Cefuroxime 750mg oral
Oral prophylaxis
Metronidazole 250 MG Oral Tablet [Flagyl]
Oral prophylaxis
Metronidazole 1 g Intravenous
IV prophylaxis
Cefuroxime 1,5 g Intravenous
IV prophylaxis
Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral
Laxative for bowel cleansing
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who voluntarily accept to join the study and sign a dedicated written consent.
* Capability of understanding the study and take the medications prescribed.
Exclusion Criteria
* Patients who refuse to participate
* Patients with rectal disease or neoplasia
* Patients with pre-existing intrabdominal sepsis (abscess, acute diverticulitis)
* Patients who received preoperative antibiotic treatment for any other reasons during the two weeks before surgery
* Patients with Crohn's disease or ulcerative colitis
* Patients unlikely to adhere to the treatment prescribed
* Patients with allergy or contraindication to the medications used in the study
* Patients who need mechanical bowel preparation
* Patients with contraindication to bowel preparation used in the study (Citrafleet®):
* Patients with kidney failure needing haemodialysis or with hypermagnesemia
* Patients with severe heart failure
* Patients with gastric or duodenal ulcer
* Patients with mechanical obstruction
* Patients with toxic megacolon
* Patients with ascites or rhabdomyolysis
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eloy Espín-Basany, MD PhD
Role: STUDY_CHAIR
Hospital Universitario Valle de Hebron, Barcelona
Gianluca Pellino, MD, PhD
Role: STUDY_DIRECTOR
Hospital Universitario Valle de Hebron, Barcelona
Alejandro Solís-Peña, MD, PhD
Role: STUDY_DIRECTOR
Hospital Universitario Valle de Hebron, Barcelona
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Jinling Hospital
Nanjing, , China
General University Hospital of Patras
Pátrai, , Greece
Humanitas Research Hospital
Rozzano, , Italy
Tomsk Oncological Hospital
Tomsk, , Russia
Hospital General Universitario Vall d´Hebron
Barcelona, Barcelona, Spain, Spain
Hospital de Bellvitge
Barcelona, Hospitalet de Llobregat, Barcelona, Spain, Spain
Hospital Universitario Cruces
Cruces, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Royal Marsden Hospital, Imperial College of London
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Francesck Mulita
Role: primary
Antonino Spinelli
Role: primary
Annalisa Maroli
Role: backup
Eugeniy Drozdov
Role: primary
Sebastiano Biondo, MD PhD
Role: primary
José María García González
Role: primary
Manuel Muinelo
Role: primary
Christos Kontovounisios
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Pellino G, Solis-Pena A, Kraft M, Huguet BM, Espin-Basany E. Preoperative oral antibiotics with versus without mechanical bowel preparation to reduce surgical site infections following colonic resection: Protocol for an international randomized controlled trial (ORALEV2). Colorectal Dis. 2021 Aug;23(8):2173-2181. doi: 10.1111/codi.15681. Epub 2021 May 12.
Willis MA, Toews I, Soltau SL, Kalff JC, Meerpohl JJ, Vilz TO. Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery. Cochrane Database Syst Rev. 2023 Feb 7;2(2):CD014909. doi: 10.1002/14651858.CD014909.pub2.
Koskenvuo L, Sallinen V. Preoperative oral antibiotics in colon surgery. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):801-802. doi: 10.1016/S2468-1253(20)30203-X. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-004283-21
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.